Devices and Methods for Weight Control and Weight Loss

ABSTRACT

The present invention provides compositions, devices; and methods for affecting, among other things, weight loss and/or weight control, by sequestering nutrients or other compounds such as toxins from absorption in the digestive tract. The compositions, devices, and methods employ one or more members made of a compressible, absorbent matrix material. In various embodiments, the matrix material is suitable for routine use. The compressible absorbent matrix material has a size, shape and/or geometry configured for efficient packing into a small space, and/or configured to absorb and substantially retain digested material in the stomach. The devices and compositions may further comprise one or more hydrogel(s), soluble or insoluble fibers, waxes and/or gums to provide the desired mechanical properties and/or absorptive or shielding properties.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation and claims the prioritybenefit of U.S. patent application Ser. No. 14/272,342 filed May 7,2014, which will issue as U.S. Pat. No. 9,320,715, which claims thepriority benefit of U.S. patent application Ser. No. 13/431,076 filedMar. 27, 2012, which will issue as U.S. Pat. No. 8,722,066, which claimsthe priority benefit U.S. provisional application No. 61/468,802 filedMar. 29, 2011, the disclosures of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to devices, compositions, and methods for,among other uses, reducing the amount of nutrients or other compoundsabsorbed in the GI tract from ingested food.

Description of the Related Art

The term “overweight” refers to body weight above a normal range.Overweight and obesity are determined by calculating the body mass index(BMI), the weight in kilograms divided by height in meters squared.Overweight is generally defined as a BMI of 25 to 29.9 kg/m², obesity isgenerally defined as a BMI of ≧30 kg/m², and severe obesity is generallydefined as a BMI ≧40 kg/m² (or BMI ≧35 kg/m² in the presence of othermedical comorbidities). A BMI less than about 22.0 kg/m² is ideal,though this may be a difficult and perhaps unrealistic goal for manyindividuals.

Overweight and obesity are worldwide health epidemics, with increasingprevalence. In the United States, more than two-thirds of Americans areoverweight and 26-55% are obese based on data collected in 2007 by theCenters for Disease Control and National Institutes of Health. Globally,overweight and obesity affects both established and developingcountries. For example, about 23% of the population in the UnitedKingdom is obese, compared to about 11-23% in Mexico, approximately30-40% in South Africa, and about 10% in Pakistan.

Overweight and obesity are associated with Many health risks includingtype 2 diabetes mellitus, hypertension, dyslipidemia, coronary heartdisease, cancer and stroke among others, as well as premature death.Compared to normal weight individuals, a BMI of 26.5 to 29.9 kg/m² isassociated with a 1.5 times increased risk of death. Those with a BMI≧30 kg/m² have a 2-3 fold increased risk of all-cause mortality. Theeconomic implications are great; a Brookings institute publicationquoted the cost to the United States of overweight and obesity to be atleast $147 billion annually. The rationale for weight reduction isclear, from both a medical and economic perspective.

Currently available methods to decrease weight include behaviormodification (dietary change and exercise regimens), drug therapy, andbariatric surgery. Drug therapy is indicated in patients who have failedto achieve weight loss goals through diet and exercise alone. The FDAhas approved two classes of medications explicitly for use in weightloss. Sympathomimetic drugs (e.g., phendimetrazine, diethylpropion,phentermine) stimulate the release of norepinephrine and/or inhibit itsreuptake into nerve terminals. In lay terms, this effect is analogousthough much stronger than that produced by caffeine. Sympathomimeticscause appetite suppression but also may cause hypertension andpotentially myocardial infarction, and as a result are limited to <12weeks of use by the FDA. Ephedrine is a member of this class that wasrecently removed from the market because of these adverse side effects.

Malabsorptive drugs are the other medication class that is FDA approvedfor use in obesity. Orlistat is the only representative of this group.Orlistat alters fat digestion by inhibiting pancreatic lipase, resultingin the malabsorption of 30% of ingested fat. Instead of being taken upby the body, this fat is excreted in stool. Orlistat is the only FDAapproved medication for obesity that is-acceptable for long term use (upto 4 years).

For patients with severe obesity, the only proven mechanism of long-termweight loss is bariatric surgery. Bariatric surgery effects weight lossthrough either malabsorption and/or restriction. Malabsorption (as withOrlistat above) means the incomplete absorption of ingested food. Thebody does not absorb the full amount of calories present in a meal or ina given food item. Restriction means a reduction in the size of thestomach, with resultant early satiety and reduced food consumption.

Overweight and obese patients who do not meet BMI criteria for severeobesity do not have surgery as an available option for weight loss, asinsurance coverage for these procedures is typically limited to theseverely obese. Accordingly, overweight and obese patients have accessto only one FDA approved medication for weight loss. Thus, there existsa great need for weight loss and weight control alternatives.

SUMMARY OF THE PRESENTLY CLAIMED INVENTION

The present invention provides, compositions, devices, and methods foraffecting (among other things) weight loss and/or weight control, bysequestering nutrients or other compounds (e.g., alcohol or toxins) fromabsorption in the digestive tract. In various embodiments, thecompositions, devices, and methods, which employ a compressible,absorbent matrix material, are suitable for routine use.

In one aspect, the present invention provides a device or compositioncomprising one or more members of a compressible absorbent matrixmaterial designed to absorb and substantially retain nutrient materialin the digestive tract, such as nutrient material present in the stomachafter a meal. The device or composition may further employ one or morehydrogel(s), soluble or insoluble fibers, waxes and/or gums to providethe desired mechanical properties and/or absorptive or shieldingproperties, as described in detail herein. In some embodiments, thedevice is in the form of a capsule comprising the matrix materialmembers, which may be in the form of tubes. Alternatively, the device orcomposition may be a food additive.

In another aspect, the present invention provides a method for absorbingand retaining (e.g., shielding) nutrients or other compounds from theabsorptive action of the digestive tract. The method comprises providingthe device or capsule for ingestion before, during, or after eating. Thesubject may be an overweight or obese subject, and the composition ordevice may be used routinely to affect weight loss. Alternatively, thesubject may be of normal weight, but in need of weight control, forexample, due to a pattern or history of being overweight.

The orally ingested device or composition in various embodimentscontains one or a plurality of “sponges” or “sponge tubes” in acompressed or dense state, and which expand once in the GI tract. Thesponge matrix or scaffolding greatly amplifies the volume displaced inthe expansion of the sponges. For example, in certain embodiments, thesponge material may itself absorb ten times or more its weight in fluid,which helps to shape the material as in a scaffolding. When the spongeexpands it doesn't just absorb ten times its volume, but soaks in allthe fluids contained in the void spaces of the scaffolding. That is, the“chambers” or “holes” of the sponge dramatically magnify the volume offluids absorbed. These fluids will be then trapped inside thescaffolding of the sponge by hydrogels in the sponge cell walls thatseal each chamber.

More particularly, the sponge absorbs portions of chyme suspension inthe stomach, reducing the amount of food available for absorption in thesmall intestine. In this manner, calories are “sequestered” from thebody, promoting weight loss. The device or composition design maximizesthe capacity and/or efficiency for nutrient absorption (and concomitantsequestration of the nutrients) and avoids the side effects associatedwith drug-based treatments for obesity. For example, the material and/orgeometry of the matrix material, together with one or more hydrogel(s),soluble and/or insoluble fiber(s), waxes) and gum(s) provides thedesired mechanical properties, including efficient packing and desiredelasticity and/or expansion of the matrix material, as well as thedesired properties for absorption of nutrients and subsequentsequestering and shielding from digestive action.

In various embodiments, the present invention helps to reverse a trendin the food industry, which has progressively reduced fiber fromfoodstuffs and has replaced it with sugars. The present invention thusalso supplies fiber to the diet while eliminating absorption of sugars.

In various embodiments, the present invention absorbs fluids rich insugars and/or alcohol, which are typically soluble, and consequently,more absorbable by the GI than other less soluble nutrients. Further,sugars and/or alcohol may not be beneficial for health. Such fluids maythen be sequestered by the compositions and devices in their nativestate and/or in a gelled or a mucilaginous state. For example, thefluids may be sequestered by absorption, reaction, or association withother compounds like soluble fibers. Accordingly, the body will “see”(e.g., will be able to absorb during digestion) fewer nutrients (e.g.,sugars, carbohydrates, fats, alcohol and spirits, etc.), and on thecontrary, will “see” more beneficial fibers.

In various embodiments, the present invention provides sequestration inthe stomach or in the gastrointestinal tract of compounds, liquids(e.g., alcohol), drugs, or other dangerous or toxic substances that werewillingly or unwillingly ingested. The composition or device has thepotential to absorb and soak ingested material, and gel it and safelyand naturally remove it from the body.

In various embodiments, the present invention provides the sequestrationof nutrients without changing an individual's usual diet, the usualtaste, and the usual quantities of food ingested by the average consumerin a significant fashion.

The device and compositions of the invention may be used routinely orchronically by the overweight and obese for sustained weight loss, or bythe normal weight individual for weight control. For example, the devicemay be used from once to twenty times weekly, for one or several years(e.g., 1, 2, 3, or more years). The device may be used from one to threetimes daily (e.g., with each meal) for one, two, or three years, ormore. Alternatively, it may be used in the short term by normal weightindividuals who have eaten excessively, and may wish to decrease thecaloric “damage” of their indulgence. Accordingly, the present deviceand methods may provide an inexpensive, safe solution to obesity andoverweight for hundreds of millions people worldwide, with thecorresponding benefits in the associated medical comorbidities, lifespan, health care expenditures and global economic burden.

The device and compositions may be used to absorb and prevent digestionor biological effects of toxins or alcohol that is willingly orunwillingly ingested. In these embodiments, the device or compositionneed not be used routinely, but may be taken with food that is at riskof containing toxin, or upon knowledge of toxin ingestion, or may beused to avoid or counter the effects of alcohol overconsumption.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 to 16 show exemplary designs for the absorbent materials.

FIGS. 17 to 20 show exemplary absorbent materials.

FIGS. 21 to 26 show other exemplary designs for devices of the presentinvention.

DETAILED DESCRIPTION

The present invention provides, compositions, devices, and methods foraffecting, among other things, weight loss and/or weight control, bysequestering nutrients or other compounds such as toxins from absorptionin the digestive tract. The compositions, devices, and methods employone or more members made of a compressible, absorbent matrix material.In various embodiments, the matrix material is suitable for routine use.The compressible absorbent matrix material has a size, shape and/orgeometry configured for efficient packing into a small space, and/orconfigured to absorb and substantially retain digested material in thestomach. The devices and compositions may further comprise one or morehydrogel(s), soluble or insoluble fibers, waxes and/or gums to providethe desired mechanical properties and/or absorptive or shieldingproperties.

The compositions and devices reduce the caloric absorption by the bodyof ingested nutrients. The method of operation of the present devicesmay be referred to as “malabsorption,” whereby nutrients are absorbed bythe matrix material (e.g., sponge material) and sequestered in the GItract. Accordingly, the sequestered-nutrients are not metabolized orabsorbed by the intestine, and are excreted with the matrix material.The devices are inert and operate in a passive fashion and do notsubstantially interfere with body metabolism. In essence, the device“shields” ingested nutrients from the absorption action of theintestinal villi and other digestive activity.

The compressible absorbent matrix material may, in some embodiments, bea sponge material, and may be in the form of “sponge tubes” and/or“sponge drops.” While tubes may be the most intuitive and simple shapefor the matrix material, the matrix material may or may not be tubularin shape, as other geometries will be suitable and/or advantageous incertain embodiments.

The sponge material may be a naturally occurring material or may be anartificially foamed type sponge comprising a multitude of open space,e.g., open or closed “cells” which may be irregular or regular in shape,and defined by the sponge matrix “cell walls”. The sponge material mayalso be a material having an alternation of empty and closed spaces,regular or irregular, having a defined geometry or amorphous, or amixture of defined and irregular or amorphous spaces. In someembodiments, the sponge material has geometrically engineered structuresable to collapse under mechanical, chemical or thermal action, or acombination thereof, and can subsequently assume an expanded shape. Theexpanded shape may be the original shape (before compression), oranother intended shape. The expanded shape generally occurs in responseto removal of the mechanical, chemical or thermal action uponinteraction with stomach contents or/and chemical interactions withsuitable additives present in the device.

The matrix material, when subject to mechanical compression, thermaland/or chemical treatment (e.g., by chemically modifying the material,crosslinking, compounding or covalent bonding compounding, etc.), can bereduced in size and/or volume to a size and/or volume that is muchsmaller than the original, uncompressed size and/or expanded volume. Thecompressible property allows for efficient packing of a plurality ofmatrix material members into a small space, such as a capsule or othervehicle for delivery. For example, the compressed size or volume may beless than about 50% of the expanded size, or in other embodiments, lessthan about 40%, less than about 30%, less than about 25%, less thanabout 20%, less than about 15%, less than about 10%, less than about 5%,less than about 1%, less than about 0.5%, or less than about 0.1% of theexpanded size or volume. Generally, after release of an appliedmechanical compression or chemical constraint (e.g., by chemicalreaction, breaking of cross-linking, etc.) or both, the material canassume its original, larger shape.

The mechanism of expansion of the matrix material may also be elasticreturn, where the material, although not elastomeric per se, may stillbe stiff enough (e.g., the molecular creep time is sufficiently long)that the material may still at least partially assume its original shapeafter a period of compression and/or stress.

The matrix material can be mechanically flattened and stacked, or simplycompressed, then encapsulated, e.g., in a conventional pharmaceuticalcapsule for ingestion. The matrix material is generally made of anelastic and/or resilient material which can be compressed and is capableof absorbing liquid and/or material in the digestive tract. The matrixmaterial generally has an internal porosity like a natural sponge. Thecells of the sponge or sponge-like material may be random and/oramorphous (e.g., as in typical commercially available artificial ornatural sponges). Alternatively, in some embodiments, the cells of thesponge material may be more regular and/or geometrically ordered, like ahoneycomb or other geometric and/or volumetric arrangement.

The geometric structure of the matrix material may also provide amagnifying and/or multiplicative effect on the expansion of the presentdevices and their digestive fluid absorption and/or retention capacity,relative to amorphous and/or non-geometric devices comprising naturalfibers. This magnifying and/or multiplicative effect can be at least 2times, at least 5 times, at least 10 times, at least 50 times, or atleast 100 times, relative to an amorphous device (e.g., a device havingan irregular shape). Accordingly, a much smaller quantity, mass, volume,dosage or amount of the present device(s) or compositions is required inthese embodiments. For example, in some embodiments, a user need onlyingest a small pill or capsule (e.g., conventionally sized pill orcapsule). In accord with the multiplicative and/or magnifying effect asdescribed herein, such a small pill or capsule may effectively provide alarge capacity for absorption of digestive fluids and, consequently,sequestration or shielding thereof from absorption by the body.

In some embodiments, the sponge material may be a conventional ornatural sponge produced by conventional methods. In other embodiments,the sponge-type material may be produced from, e.g., foaming agents,reactive agents, percolating agents, and may be formed by extrusion,blow-molding, injection molding, thermoforming, mechanical or chemicalcarving and shaping, etc. Alternatively, the sponge material may be madeby assembling of smaller segments and/or geometrical and/or randomshaped units into larger units, allowing for careful selection of thesponge morphology. For example, the sponge material may be made byextrusions processes, blow-molding processes, injection or thermoformingmolding processes., or may be mechanically and/or chemically printed ormechanically carved or formed. The sponge material may be partially ortotally elastic., elastomeric, resilient or not, recoiling, or partiallyrigid or semi-rigid, and/or plastic. FIGS. 17-20 illustrate certainexemplary sponge materials which may be suitable for use in the presentinvention.

The sponge material is typically selected such that the cell walls willhave “shape memory,” namely, the cells generally at least partiallyreturn or expand to their original size and/or shape once an appliedmechanical and/or chemically compression force is released.

The mechanism of expansion of the released sponge material may be, e.g.,through the return of a shape memory material such that at physiologicalconditions in the stomach (e.g., at 37 ° C.) the material assumes atleast partially its original shape. Elastomeric or resilient materialmay be employed for the sponge material, e.g., elastomeric, materialslike latex, guayule, polyurethane rubber, silicon rubber, cellulose,nanocellulose, nitrile rubber, or biological materials such as elastin,collagen and/mother natural proteins, or any other suitable materialsthat can retain and conserve their original shape after extended periodsof time under compression, or which return to the memory shape or assumea different shape. Alternatively, the mechanism of expansion may helargely clue to fluid absorption of the sponge, for example, whenincluding such materials as hemicellulose, which has a high absorptionstrength, and is able to create a hydraulic force to inflate the spongescaffolding.

The sponge matrix can be made of material safe for human ingestion.Examples of suitable materials include: polymer or copolymer ofpolyurethane, nylon, polyethylene, polypropylene, polyacrylate, EVA,natural rubber, silicon, silicon rubber, latex, epdm rubber, butilerubber, nitrile rubber, PVA, PLA. Suitable elastomeric biomaterialsinclude silicones, thermoplastic elastomers, polyolefin and polydieneelastomers, polyvinyl chloride), natural rubber, guayule rubber,heparinized polymers, hydrogels, polypeptides, and elastomers, which maybe compounded with other polymer or natural or artificial elastomers andor fillers like clay, starch, elastic fibers, elastic microfibers,elastic nanofibers, which may be further compounded with inert and/ornatural compounds, such as cellulose and its derivates, elastic andnon-elastic fillers and powders.

Other suitable materials for the matrix include natural polymers such ascellulose, nanocellulose, bacterial cellulose, cellulose fibers,microfibers and nanofibers, methylcellulose, ethylcellulose,ethylmethylcellulose, other cellulose derivatives, cellulose compoundedwith natural or synthetic or artificial elastomers and/or fillers andnatural hydrogels like chitosan, opuntia, and other disaccharides, andnatural clays (e.g., montmorillonite).

In certain embodiments, a sponge material may be employed which providessubstantially all of the desired properties, e.g., swelling, absorbingsoaking, shielding, retaining, disintegrating, and may further hebiocompatible, biodegradable and may comprise only natural materials.

In embodiments where disintegration of the matrix material in the GItract is appropriate or indicated, biodegradable fillers, compounds orfibers can be employed. The partial or total disintegration of thesecompounds, fillers or fibers in the digestive tract may induce thepartial or total collapse of the sponge material. Accordingly, anaverage disintegration time of the material may be effected by adjustingthe proportion of such additives. Exemplary fillers may include starchesand/or other polysaccharides.

The size of the sponge matrix may range from, for example, a diameter ofabout 1 nm to about 25 mm, or about 1 μm to about 100 μm. The length ofthe present sponge tubes may range from, for example, about 1 μm toabout 3″. Accordingly, the geometry of the present “tubes” may varyaccording to the selected width and length. Furthermore, different sizesand shapes of sponges may be employed to selectively capture differentparticulate sizes and/or suspensions and/or colloids. Accordingly, acapsule may contain an assortment of sponges having various externalgeometries, sponge materials, sponge morphologies, etc.

Further, the sponge geometry may be selected to maximize packing orstacking efficiency, or maximize the number of sponges which may becompressed in a capsule, thereby maximizing the nutrient sequestratingcapacity of each capsule.

The compositions and devices may further comprise other natural orsynthetic materials to provide the desired mechanical properties, ordesired absorptive and/or shielding properties.

In order to protect fluids absorbed by the present devices from beingsubsequently released, the fluids should be kept inside or sequesteredin the matrix material once absorbed. Additionally, absorbed fluids ormaterials should be shielded from exposure to digestive enzymes.Accordingly, absorbed fluids may be gelled or made more viscous.Nutrients thus captured may be sealed or sequestered inside the tubes byone or more hydrogel(s), fiber(s) and/or gum(s). Such hydrogel(s),fiber(s) and/or gum(s) may be directly incorporated into the spongematerial, compounded in the sponge walls matrix, contained and/ordispersed inside the sponge cells, or located at particular areas of thetubes, for example, the entrances or openings of the tubes as describedherein.

Without being bound to any specific theory or explanation of the mode ormechanism of action, the present devices may act in part in a manneranalogous to the behavior of dietary fiber (e.g., soluble and/orinsoluble fiber) in the digestive system. That is, the compositions anddevices may decrease and/or slow the absorption of nutrients, and/or mayaccelerate the passage of nutrients in the gastrointestinal tract. Thus,in certain embodiments, the compositions and devices may contain as muchnatural fiber as possible, either soluble, insoluble, or a combinationof both. In certain embodiments, a combination of soluble and insolublefibers are employed. Insoluble fibers may be included to provide, interalia, desired mechanical properties as described herein includingexpanding and shielding. Insoluble fibers may also be included for theirmucillagenic properties of gelling of fluids and/or increasing theviscosity of entrapped, bound, encapsulated or entrained fluids.

Non-limiting examples of suitable hydrogels include: polyvinyl alcohol,poly(ethyloxazoline), polyvinylacetate-polyvinylalcohol copolymers,poly(2-hydroxyethylacrylate), poly(2-hydroxyethylmethacrylate),carboxymethylcellulose, polyacrylic acid, and copolymers thereof,disaccharides, polysaccharides, chitosans, alginates, water solubleproteins, and polynucleic acids, natural clays (e.g., montmorillonite),sodium bentonite, absorbent fibers, super absorbent fibers, micro andnanofibers, micro and nanopowders, and combinations thereof.

Mixing of hydrogels and/or mucilage and/or gum forming compounds in thesponge material may result in the cells, pores or walls of the spongesbecoming less permeable, and accordingly may inhibit entrance or exit offluids after initial absorption or sequestration of digestive fluids.There are many different compounds that can achieve this effect,artificial and/or natural. Exemplary natural compounds may includesoluble fibers, gums, etc. as described hereinabove. Individualhydrogels, gums or fiber material, or mixtures thereof may be selectedto provide a desired absorption profile and/or other desired properties(e.g., expansion properties, absorption capacity, mechanical properties,etc.).

The hydrogel(s), fiber(s) and/or gum(s) dispersed in the sponge matrixor added thereto and contained mechanically in the tubes or tube cellsmay seal the cells, creating a multitude of sealed or partially sealedcompartments where the movements of fluids may be partially orcompletely restricted in order to prevent leakage of absorbed nutrientsor penetration by digestive enzymes as the sponge travels the GI tractprior to excretion. The hydrogel(s), fiber(s) and/or gum(s) in thesponge cell walls will swell up with fluids until the expansion of thesponge cells will seal totally or partially the axial holes. Anothereffect of the hydrogel(s), fiber(s) and/or gum(s) may be to make thesponge tube more mechanically stable or robust, in order to betterresist the final passage in the colon in the event the tubes are to benaturally expelled by the body.

In some embodiments, nutrients are trapped in the sponge by thehydrogel(s), fiber(s) and/or gum(s), and the sponges then disintegrateafter passage through the upper GI tract. For example, these componentsmay disintegrate after the portions of the GI tract where most nutrientabsorption occurs, such that mechanical stability may not be necessary.In this case, the sponge material can be selected such that the materialat least partially or totally disintegrates in the lower GI tract, toassure safety in the case of excessive consumption of tubes or in aclinically slow discharging intestine (e.g., to avoid intestinalblockages).

In some embodiments, the compositions and devices comprise insoluble andsoluble dietary fibers, such as resistant starches, non-resistantstarches, and non-starch polysaccharides. Examples includearabinoxylans, cellulose, dextrins, inulin, lignin, waxes, chitins,pectins, beta-glucans and oligosaccharides, including galactosaccharidesand fructo-oligosaccharides. Other exemplary polysaccharides includeetheropolysaccharides like pectines. The compositions and devices mayemploy a mixture of different insoluble fibers, mixtures of differentsoluble fibers, and/or mixtures or one or more of each of insoluble andsoluble fiber(s). In certain embodiments, a mixture of the two types offibers (e.g., insoluble and soluble) may be employed. Insoluble fiber(s)may provide a “sponge” skeleton and/or may provide a shieldingfunctionality.

In certain embodiments, the composition or device comprises one or moresoluble fiber(s) selected from an exopolysaccharide mucilage. Theexopolysaccharide mucilage may he from Aloe vera, Basella alba (Malabarspinach), Cactus, Chondrus crispus (Irish moss), Dioscorea opposita(Nagaimo, Japanese mountain yam), Drosera (sundews), fenugreek, flaxseeds, kelp, liquorice root, marshmallow, mullein, okra, Parthenium,Pinguicula (butterwort), psyllium seed husks, Salvia hispanica (chia)seed, Ulmus rubra bark (slippery elm), or any other suitable plant.

In these and other embodiments, the compositions and devices maycomprise cellulose or derivatives of cellulose like methyl cellulose,ethyl cellulose, and/or methyl-ethyl cellulose.

In these and other embodiments, the compositions and devices maycomprise natural gums, such as those that may be obtained from seaweedsand other sources. Such compounds include polyelectrolytesagar (E406),alginic acid (E400) and sodium alginate (E401); and Carrageenan (E407).Natural gums obtained from non-marine botanical resources includepolyelectrolytes: gum arabic (E414) from the sap of Acacia trees, gumghatti from the sap of Anogeissus trees, gum tragacanth (E413) from thesap of Astragalus shrubs, and karaya gum (E416) from the sap ofSterculia trees. Other natural gums include guar gum (E412) from guarbeans, locust bean gum (E410) from the seeds of the carob tree,beta-glucan, from oat or barley bran, chicle gum obtained from thechicle tree, dammar gum from the sap of Dipterocarpaceae trees,glucomannan (E425) from the konjac plant, mastic gum, a chewing gumobtained from the mastic tree. In certain embodiments, the mucilagematerial includes Psyllium seed husks from the Plantago plant, sprucegum from spruce trees, tara gum (E417) from the seeds of the tara tree,and/or natural gums produced by bacterial fermentation, e.g.,polyelectrolytes: gellan gum (E418) and xanthan gum (E415). Fibers ofanimal origin, such as keratins (e.g., silk, etc.), elastin and/orcollagen may also be employed. These natural gums or fibers may beobtained from commercial sources.

The hydrogel(s), fiber(s), waxes, and/or gum(s) may provide anadditional mechanism (or force) for expansion of the matrix material, byproviding a chemical expansion, e.g., via absorption of water and otherfluids. For example, the matrix material may expand, or hydrogel(s),fiber(s) and/or gum(s) which may be present in the sponge cell walls mayabsorb water and fluids and stiffen the cell walls to return the spongetube at least in part to its original size and/or shape prior tocompression and/or stacking.

In some embodiments, the device or composition comprises hemicelluloseor xylan, alone or compounded chemically and mechanically. This shortchain polysaccharide (hemicellulose) is inexpensive and has a greatcapacity to absorb fluids. For example, the device or composition maycomprise hemicellulose-citrate-chitosan, in an aerogel foam, which isboth elastic and extremely absorbent. In these or other embodiments, thedevice or composition comprises, or further comprises one or morefillers such as crystalline cellulose and/or amorphous cellulose, ligninor other stiffening compounds. In such embodiments, an expansionmechanism of the matrix is in part a result of absorption of fluids,which may stiffen the scaffolding material of the sponge, and maymagnify the total expansion.

In some embodiments, the composition or device comprises an ester ofhemicellulose with organic acid (e.g., having carboxylic groups).Examples include hemicellulose citrate, hemicellulose acetate, and otherorganic acids, which make a foam having desirable flexibility andelastic recoil. In other embodiments, the composition or devicecomprises hemicellulose alone or with chitosan. Still further,embodiments of the device or composition may employstarch-citrate-chitosan, starch-chitosan, orstarch-hemicellulose-chitosan.

In order to obtain the desired gelling action, additional compounds maybe included, in the presence or absence ofhemicellulose-citrate-chitosan. Such compounds include various types ofcellulose or other artificial and synthetic compounds, such as one ormore of: bovine serum albuminate pectinate, pectin-ethyl cellulose,calcium pectinate and chitosan, naproxen pectin, de-esterified pectin,zinc-pectinate gels, amylose, chondroitin-sulfate (crosslinked oruncrosslinked), cyclodextrins, dextran, calcium alginates and alginates,locust bean gum, guar gum, glutaraldehydes, and epiclorihydrine. Forexample, in certain embodiments, guar gum is employed, which may becompounded or just dispersed in the hemicellulose matrix foam sponge.

Another mechanism for expansion of the matrix material may includeincorporation of a combination of compounds and/or protein-likesubstances or structures, arranged in a fashion analogous to musclestructure, wherein the shrinking, expanding and/or twisting of onecomponent with respect to another may cause a rolling and/or twisting orexpanding action, resulting in the expansion of the material.

Still another mechanism for releasing the compressed matrix material mayinclude foaming and/or gas releasing agents activated by the heat and/oracid environment of the stomach, which may produce gases and/or foamingto expand the material (e.g., NaHCO₃, etc.). As such, in the case of asponge material reacting to the acidic environment of the stomach, allor part of the material of the sponge may react with the stomach acid,increasing at least partially in volume, and returning the sponge to itsoriginal shape. The matrix material, which is typically released intothe stomach after dissolution of a capsule (e.g., a gelatin capsule orthe like) containing the compressed material, typically expands insidethe stomach and absorbs the fluids therein.

Yet another mechanism of expansion may include electrostatic and/ormagnetic repulsion and/or attraction of some parts of the sponge withother parts of the sponge, or the electrostatic interactions or a tubewith another tube or similar entity included in the pill or introducedinto the stomach independently. In still other embodiments, the matrixmaterial might be introduced as twisted shapes with an elastic expansionmechanism as described above, which can then untwist and expand.

In certain embodiments, the capture of nutrients may also be caused bythe twisting (e.g., like the wrapping of a caramel) or rolling of thematrix material. In such cases, the matrix material may have a flatgeometric configuration, although such a mechanism may be possible withother shapes and may also comprise an absorbing mechanism associatedwith the sponge material. Such twisting and/or rolling may be caused orinduced by one or a combination of the above mentioned mechanisms.

The matrix material may be cylindrical, and may have an elliptical,oval, square, rectangular, triangular or polygonal or trapezoidalcross-section or shape. Further, various regular or irregular shapes orcross sections may be used in forming the compositions and devices, anda given “tube” may comprise one or more discrete domains of a particularshape or cross-section. The geometries and cross sections may supportefficient packing, e.g., into capsules, such that a sufficient amount of“tubes” may he delivered in a small space. The geometries, crosssections, and opening configurations may further allow efficientabsorption of stomach digestion products. Mixed geometries or shapes arealso possible. FIGS. 1-16 illustrate a number of exemplary shapes andcross-sectional geometries. Further, as illustrated, the matrix materialwill typically have one or more axial openings or holes along itslongest axis, although more than one hole may exist along essentiallyany axis. FIGS. 1-16 illustrate a number of possible holeconfigurations.

The hole(s) may be centered along the main axis (e.g., along the longestside) of the tube, or may be off center. The hole(s) can have acircular, star, cross or other segmented geometry (see FIGS. 1-16). Thepurpose of this hole is to facilitate rapid absorption of nutrients inthe stomach. The sponge architecture with holes is designed tofacilitate the entrance and capture inside the sponge of larger sizedparticulates that otherwise might be absorbed in the interior of thesponge. Furthermore, the hole(s) generally decrease the volume of thecompressed tube inside the capsule, so more tubes can be accommodate ina single capsule and a larger volume of nutrients can be sequestrated orwith a single pill.

In some embodiments, the device or composition may comprise one or morereleasing agents in the cavity or in the cavities, or in cells of thesponge, in order to avoid sticking between the walls of the cell. Suchreleasing agents could be natural or artificial waxes, wax compoundswith a gum for elasticity, or just a small layer of a polymer such aspolyethylene compounds or polyethylene glycols or just polyethylene. Incertain embodiments, the releasing agent dissolves in the stomach or isa natural foaming agent (e.g., baking soda).

The external skin of the matrix material can be essentially intact,smooth and free of perforations or holes, or may have some holes, whichmay be small in some embodiments. Such totally or partially intact skinmay avoid loss of absorbed nutrients from the matrix material due tomechanical and enzymatic action of the digestion. However, in someembodiments, the exterior of the matrix material is essentially the sameas the interior, and maybe perforated or the like.

Nutrients to be absorbed generally enter the matrix material via theopenings, which may be present at the ends where no skin is present, orat the open ends of holes through the tubes. The sponge geometry and thenumber and placement of tubes in the sponge can be selected toaccommodate the greatest possible number of tubes inside a fixed capsulevolume, to assure the best possible shape memory return once the tubesare released from the capsule, to maximize absorption of each tube, or acombination of these or other factors.

The matrix material may be manufactured by normal extrusion, or byfoaming of a block of material, after the mechanical cutting of thedesired shape. Alternatively, the matrix material could be punched froma fast advancing strip. The matrix material may be encapsulated by niprolling a sheet of the sponge material. The rolls may be running filmsof a packing or protecting compounds, as used often in thepharmaceutical industry. For example, the material may be PLA or othernatural or artificial material. The nip rolls compress and cut thematrix material at the same time, and in other rolls print and seal thefilms around the sponge. A plurality of these printed sponges containedby the double films are deposited in a normal gel cap capsule or othersimilar container. A similar process, although more miniaturized, couldbe employed to make sponges for premixing with food products. The“sponge” matrix, scaffolding, could alternatively be manufactured bymechanically punching holes in the main scaffolding material (e.g.,foam), and after folding the holed, cored, celled material on itself,rolling or folding, and gluing or mechanically fastening the holed stripin order to retain a three dimensional structure, and then compressingand encapsulating it. The rolls could further be designed, not just toflatten the sponges, but to give a lateral compression as well.

Depending on the size, the invention may employ encapsulation,microencapsulation, or nanoencapsulation of the matrix material. Suchencapsulation techniques as known, for example, and are used formicronutrients or drug delivery. In some embodiments, the devices andcompositions arc encapsulated with casein. Techniques for micro ornanoencapsulation include: pan coating, air suspension coating,spray-drying, ionotropic gelation, coacervation, in situ polymerization.In other embodiments, the sponges are encapsulated by freezing in acompressed state. With a small amount of water, once compressed andfrozen, the sponge matrix will stay compressed allowing easyencapsulation.

For weight loss or weight control, the composition or device asdescribed is ingested before, during or after meals or any other foodingestion, e.g., breakfast, a snack, etc. The capsules can be speciallytailored for large or small size human bodies and/or for light or heavymeals by adjusting the capsule size, and accordingly, the number oftubes and the total absorptive capacity of the capsule. Once a capsulecomprising. For example, the “sponge tubes” is ingested and in thestomach or the intestine, the capsule dissolves, releasing the tubeseither all at once, or in groups (e.g., in delayed release). Thereleased tubes, no longer mechanically or chemically constrained by thecapsule, will then expand, absorbing, capturing, enclosing, soaking somefraction of the contents of the stomach or intestine present at themoment of the tubes are released.

In some embodiments, the composition or device may be used directly infood products (e.g., mixed therewith) to reduce the caloric content ofthe food containing the devices. For example, the present devices may bedispersed, added, and/or mixed in a food product, or included as aseparate component in a packaged food product for addition to the foodproduct (e.g., in prepackaged food products, with food served at arestaurant, or with food at home, in beverages, etc.). In oneembodiment, the present devices) (e.g., capsules, etc.) may be scaled orsized such that they may he mixed with or added to prepared foods. Forexample, small sponge “drops” having, e.g., spheroidal or ellipsoidgeometry, with dimensions of, for example, less than about 500 less thanabout 250 less than about 100 less than about 50 less than about 40 lessthan about 30 less than about 20 less than about 10 less than about 5 orless than about 1 (or any other value or range or values therein ortherebelow) could be on or in, e.g., chocolate, spreads, jams, peanutbutter, butter, cereals, flours, sweets, candies, cakes, dough, pastas,sugars like sucrose or fructose or high fructose corn syrup, even softor alcoholic drinks, juices and/or any other food generally for sale orserved in restaurants.

The small size of these capsules may allow them to avoid being destroyedduring mastication, and may render them undetectable by the taste buds.For example, the compositions may be tasteless, and/or may be scaledsuch that they provide a smooth “mouthfeel”. Once in the stomach, thedevices or “drops” would be released from any encapsulating material andcould then expand, absorb fluids, and, in embodiments wherein thedevices are designed to do so (e.g., as described herein), gel theabsorbed or encapsulated fluids.

In the case where foods which contain the present devices requirefurther cooking and/or preparation (e.g., flours, pasta, etc.), anencapsulation material may be selected to resist exposure to heat and/orexposure to cooking fluids. Such encapsulation may be effected bymaterials that may resist such thermal and/or fluid exposure, but mayotherwise degrade or dissolve in the GI tract. For example, anencapsulation material may be selected that is heat resistant and/orheat stable, and fluid resistant at normal pH, but dissolves in anacidic environment (e.g., such as that in the stomach). Exemplarymaterials include polylactic acid (PLA), which may be resistant totemperatures as high as 190 degrees centigrade.

The device and compositions may be used to absorb and prevent digestionor biological effects of toxins or alcohol that is willingly orunwillingly ingested. In these embodiments, the device or compositionneed not be used routinely, but may be taken with food that is at riskof containing toxin, or upon knowledge of toxin ingestion, or may beused to avoid or counter the effects of alcohol overconsumption.

The following non-limiting examples will illustrate various aspects ofthe present invention. The examples should, of course, be understood tobe merely illustrative of only certain embodiments of the invention andnot to constitute limitations upon the scope of the invention which isdefined by the claims that are appended at the end of this description.

EXAMPLES

In one example, a commercially available pure cellulose sponge wasobtained. The sponge was cut into small tube-like shapes having adiameter of approximately 3-4 mm and a length of approximately one inch.The strips were then coated in carboxymethylcellulose (CMC) powder (ahydrogel). The cut, hydrogel coated strips were then inserted intopolyethylene terephthalate (PET) tubes having approximately 6 .mu.mthick walls (e.g., 1/10 .sup.th the thickness of a hair) and an internaldiameter of about 4-5 mm. A batch of approximately 100 of these PETtubes filled with sponges was prepared.

Bundles of 20 of these sponge-filled PET tubes were then alignedlongitudinally, compressed, and inserted in gelatin capsulesapproximately 25 mm long and approximately 9 mm in diameter to form“pills.” Each pill weighed approximately 500 mg.

Commercially available canned chicken soup was obtained and poured intoa plastic container. Sugar, salt, and lemon juice were added to thechicken soup to simulate the conditions (e.g., acidity) and contents ofthe stomach after food has been ingested. The mixture was then warmed toa temperature of about around 35-40 ° C.

One pill, prepared as described above, was then placed in the mixture,and the mixture was stirred for several minutes. After approximately 2.5minutes, the gelatin capsule dissolved and began releasing the sponges.The sponges released from the dissolving gelatin capsule began to swell.Stirring was continued for approximately 10 minutes.

The soup-saturated sponges were then removed from the mixture with astrainer and weighed. This experiment was repeated another 4 times, fora total of five experiments. The total weight of the sponges ranged fromabout 13 grams to about 19 grams.

The sponge tubes were more rigid after absorbing the soup mixture. Thefluid mixture had entered the sponge cells, wherein those fluids weregelled by CMC. Thus, in an exemplary experiment, from an initial weightof 0.5 grams to a final weight of 19 grams, the sponges had absorbedapproximately 18.5 grams of the soup mixture.

Based on a an estimated caloric content of the soup mixture of about 4kcal/g, and taking in consideration the dilution of the soup with water,it was calculated that an exemplary pill could absorb approximately 72kcal of nutrients, which would be sequestered from absorption andmetabolism in the GI tract. Thus, for example, 5 pills as describedwould be able to sequester nutrients equivalent to a small hamburgerfrom the daily diet of a user. Accordingly, a person consumingapproximately 5 of the exemplary pills with food could loseapproximately 15 pounds of body weight per year.

Further development and refinement of the present sponge materials,geometries thereof, hydrogels employed, and packaging of the sponges asdescribed herein will significantly improve the caloric absorptioncapacity of the present sponges and pills containing the same. Forexample, a sponge pill having an approximate volume of 2.5 cm.sup.3,containing sponges prepared from a sponge material that expands andabsorbs approximately 100 times its original volume, could capture up toapproximately 250 cm.sup.3 of fluid. That volume (i.e., 250 cm₃) equatesto at least 250 grams of nutrients, and therefore may achieve a caloricsequestration of approximately 1,000 kcal per pill.

The embodiments described herein and illustrated by the foregoingexamples should be understood to be illustrative of the presentinvention, and should not be construed as limiting. On the contrary, thepresent disclosure embraces alternatives and equivalents thereof, asembodied by the appended claims.

1. A device for preventing absorption of compounds in the stomach, thedevice comprising: a plurality of compressible absorbent matrixmaterials, wherein each matrix material has a compressible architecture,and wherein each matrix material includes: one or more openings thatfacilitate nearby compounds entry into the matrix material, one or morespaces within the matrix material that stores the nearby compounds thatentered the matrix material via the one or more openings, a plurality ofcell walls that forms the compressible architecture for the matrixmaterial, wherein the plurality of cell wells at least partially returnor expand to their original state from a compressed state, and whereinthe returning or expanding is triggered via a force, and one or morefluids or materials associated with the plurality of cell walls thatprevent the compounds stored within the matrix material from leaving thematrix material; and a capsule that contains the plurality of thecompressible absorbent matrix materials in a compressed state, whereinthe capsule is ingestible by a user, and wherein ingestion is the forcethat triggers the returning or expanding of the cell walls of the matrixmaterial from the compressed state to the original state.
 2. The deviceof claim 1, wherein the one or more fluids or materials associated withthe plurality of cell walls includes hydrogels, fibers or gums that sealthe one or more spaces within the matrix material preventing absorbedcompounds from leaving the one or more spaces within the matrixmaterial.
 3. The device of claim 1, wherein the compressiblearchitecture collapses under mechanical, chemical, or thermal action. 4.The device of claim 1, wherein the compressible architecture of thematrix material in the compressed state has a compressed size or volumeless than 50% of the size or volume of the matrix material in theoriginal state.
 5. The device of claim 1, wherein the matrix material ispartially or completely elastic, elastomeric, resilient, recoiling,rigid or semi-rigid.
 6. The device of claim 1, wherein the matrixmaterial is plastic.
 7. The device of claim 1, wherein the matrixmaterial includes latex, guayule, polyurethane rubber, silicone rubber,cellulose, nanocellulose, nitrile rubber, elastin, collagen or naturalproteins.
 8. The device of claim 1, wherein the one or more fluids ormaterials associated with the plurality of cell walls includes materialsthat have high absorption strength that create a hydraulic force used toinflate the matrix material in the compressed state.
 9. The device ofclaim 1, wherein the matrix material includes biodegradable fillers thatdisintegrate in the lower GI tract, wherein the biodegradable fillersinclude starches or polysaccharides.
 10. The device of claim 1, whereinthe plurality of compressible absorbent matrix materials containedwithin the capsule each have a different shape and size.
 11. The deviceof claim 1, wherein the matrix material twists or rolls as it returns orexpands from the compressed state to the original state, wherein thetwisting or rolling facilitates capture of compounds in the stomach. 12.The device of claim 1, wherein the capsule dissolves in an acidicenvironment, and wherein the acidic environment is the stomach.
 13. Thedevice of claim 1, wherein the capsule includes polylactic acids thatresists temperatures as high as 190 degrees centigrade.
 14. The deviceof claim 1, wherein compounds absorbed by the matrix material alsoincludes toxins or alcohol.